Suction Drain in Axillary Lymph Node Dissection for Malignant Melanoma

Malignant Melanoma Clinical Trial

Official title:

Suction Drain Volume Following Axillary Lymph Node Dissection for Malignant Melanoma - When to Remove Drains? A Retrospective Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648163
• Other study ID #: 29-607
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: November 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Postoperative complications like seroma formation and wound site infection readily occur following completion axillary lymph node dissection (ALND) for malignant melanoma. We analyzed the impact of time-to-drain removal and drainage volume on seroma formation after ALND.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: September 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• histologically confirmed malignant melanoma
• underwent axillary lymph node dissection (level I-III)
• daily drainage volume records over a two-week period available

Exclusion Criteria:

• daily drainage volume records over a two-week period not available

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily drainage volume during hospitalization	The daily drainage amount durin hospital stay	through study completion, an average of 1 year
Primary	total drainage volume during hospitalization	The total drainage amount during hospital stay	through study completion, an average of 1 year
Primary	time-to-drain removal	The timepoint when the drain was removed	through study completion, an average of 1 year
Primary	evacuation of seroma after drain removal	If evacuation of seroma after drain removal was needed	through study completion, an average of 1 year
Secondary	demographic data - age	age	through study completion, an average of 1 year
Secondary	demographic data - sex	sex	through study completion, an average of 1 year
Secondary	demographic data - BMI	body mass index (BMI)	through study completion, an average of 1 year
Secondary	demographic data - smoking	smoking	through study completion, an average of 1 year
Secondary	demographic data - Diabetes mellitus	diabetes mellitus	through study completion, an average of 1 year
Secondary	demographic data - allergies	allergies	through study completion, an average of 1 year
Secondary	intraoperative parameters	surgical procedure time	through study completion, an average of 1 year
Secondary	intraoperative parameters - site	site	through study completion, an average of 1 year
Secondary	Amount of histologically analyzed lymph nodes	The amount lymph nodes found at histological analysis	through study completion, an average of 1 year
Secondary	Surgical complications	graded by the Clavien-Dindo-classification ( 1:normal postoperative cause without need of pharmacological treatment ; 2: pharmacological treatment ; 3: surgical, endoscooic or radiological treatment; 4: live-threating complications; 5: Death	through study completion, an average of 1 year